BridgeBio Seeks FDA Approval of Acoramidis in Transthyretin Amyloid Cardiomyopathy
By Colin Kellaher
BridgeBio Pharma has filed for U.S. Food and Drug Administration approval of its acoramidis drug candidate for the heart disease transthyretin amyloid cardiomyopathy, or ATTR-CM.
The Palo Alto, Calif., biopharmaceutical company on Tuesday said the filing is based on positive results from a Phase 3 study, including an 81% absolute survival rate.
Pfizer's tafamidis, which the drugmaker sells as its Vyndaqel/Vyndamax family, is currently the only approved U.S. treatment for ATTR-CM, a disease in which abnormal protein builds up on the heart and can lead to heart failure.
BridgeBio said the FDA has a 60-day filing review period to determine whether the application is complete and accepted for review, adding that it plans to submit additional applications to global health authorities in 2024.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 05, 2023 08:37 ET (13:37 GMT)
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